Status:
COMPLETED
Creating Live Interactions to Mitigate Barriers
Lead Sponsor:
Posit Science Corporation
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study is a validation study to evaluate the acceptability, feasibility and impact of a mobile psychosocial intervention to enhance social functioning in people with schizophrenia.
Detailed Description
The goal of this study is to employ an innovative and evidence-based mobile intervention that includes a neuroscience-informed computerized social cognition training program, a Health Insurance Portab...
Eligibility Criteria
Inclusion
- Participants must have a clinical diagnosis of Schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID)
- Participant must be clinically stable (outpatient status for at least 2 months) at time of screening
- Participants taking psychiatric medications must be on a stable medication regimen for greater than or equal to 4 weeks prior to screening
- Participant must be a fluent English speaker
- Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
- Participants must be able to use iOS mobile applications
Exclusion
- Participants with unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic disorder, epilepsy, recent hospitalization, ongoing chemotherapy or other cancer treatment
- Participant has a history of mental retardation, pervasive developmental disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
- Participants who have had psychiatric hospitalizations in the 8 weeks prior to randomization
- Participants had significant medication or clinical status changes, or adjustment in their antipsychotic treatment in the 4 weeks prior to randomization
- Participants with active suicidal ideations and/or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
- Participants with problems performing assessments or comprehending or following spoken instructions
- Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
- Participant is using computer-based cognitive training programs or has used it within a month of the consent date
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03317769
Start Date
April 1 2018
End Date
June 6 2019
Last Update
July 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Posit Science Corporation
San Francisco, California, United States, 94111